- In a randomized, double-blind study of 17,802 patients with LDL "bad"
cholesterol < 130 and C-reactive protein (hsCRP) greater than or equal to
2, those given rosuvastatin over a media of 1.9 years had 31 heart attacks
and 33 strokes compared to 68 and 64, respectively, in those on placebo.

- Subgroup analysis showed similar findings across gender, race,
ethnicity and Framingham risk score greater than or less than 10 percent.

NEW ORLEANS, Nov. 11 /PRNewswire-USNewswire/ -- A lipid-lowering drug
reduced heart attacks by 54 percent in people who had normal cholesterol
but elevated levels of high sensitivity C-reactive protein (hsCRP),
according to a study presented at the American Heart Association Scientific
Sessions 2008. Rosuvastatin in the Prevention of Cardiovascular Events
Among 17,802 Men and Women with Elevated Levels of C-Reactive Protein: the
JUPITER Trial was presented as a late-breaking clinical trial. The study
was simultaneously published in the New England Journal of Medicine.

"Compared to those who received placebo, patients receiving the drug
rosuvastatin also had a 48 percent reduction in stroke, a 46 percent
reduction in the need for interventions to reopen blocked blood vessels and
a 20 percent drop in all-cause mortality," said Paul M. Ridker, M.D., lead
author of the study and director of the Center for Cardiovascular Disease
Prevention at Brigham and Women's Hospital, Boston, Mass.

Patients included in the trial were men over age 50 and women over age
60, with no history of cardiovascular disease (CVD), with LDL ("bad"
cholesterol) levels <130 mg/dL and hsCRP greater than or equal to 2 mg/L.
They could have other risk factors for CVD, such as high blood pressure up
to 190/100, obesity, current smoking, abnormal glucose tolerance (but not
frank diabetes) and/or the metabolic syndrome, and/or a family history of
premature heart disease. About half had a Framingham risk score (FRS) less
than or equal to 10 percent and half >10 percent (10 percent to 20 percent
indicates an intermediate risk level). While they had not had any
cardiovascular event, those with a FRS >10 would be considered to be at
higher risk for such events than a low risk or completely healthy
population. More than 89,000 patients were screened to find the 17,802 who
participated. Most of those excluded had either LDL levels that were too
high or hsCRP levels that were too low.

Overall, compared to placebo-treated participants in the trial, those
given rosuvastatin had a 44 percent reduction in the primary endpoint of a
first major cardiovascular event -- a composite of heart attack, stroke,
revascularization, hospitalization for unstable angina and cardiovascular
death. Hospitalizations for cardiac reasons were also reduced and the
authors suggested that the strategy tested in JUPITER of treating elevated
hsCRP patients with statin therapy could be cost-effective.

Ridker said one particularly striking finding was a 37 percent
reduction in first events in men and women in the statin group who had no
other risk factors except for elevated hsCRP, a sign of inflammation that
can be associated with increased coronary disease risk.

The researchers found no increase in the number of patients with either
muscle pain or cancer among those given rosuvastatin. As in almost all
prior statin trials, they observed a small increase in reported diabetes,
said Ridker, the Eugene Braunwald Professor of Medicine at Harvard Medical
School.

The very low LDL levels produced by rosuvastatin (median 54 at 24
months) raise the question of whether other adverse effects might be seen
over a longer time period, but they were not evident here.

Low-density lipoprotein (LDL) is a component of total cholesterol
thought to contribute to plaque buildups that narrow arteries, a process
called atherosclerosis. JUPITER participants had average LDL levels of 108
milligrams per deciliter (mg/dL) at the study's start -- well below the 160
mg/dL level at which doctors normally consider beginning treatment with
statins to lower cholesterol.

The study did not provide details as to how patients with hsCRP levels
>10mg/L were handled. The 2003 consensus statement by the Centers for
Disease Control and Prevention and the American Heart Association suggests
that many elevations at those levels are due to transient inflammation from
minor infections and that patients should have the test repeated to
properly determine their chronic hsCRP level.

The 17,802 participants, recruited from 1,300 clinical sites in 26
countries, were randomly assigned to 20 milligrams (mg) of rosuvastatin a
day or a daily placebo. The study's independent data and safety monitoring
board ended the trial in March 2008, more than two years ahead of schedule,
when it determined that the study data indicated "unequivocal benefit of
rosuvastatin" on coronary-related death and disability.

"Not only do we confirm that apparently healthy men and women with
elevated hsCRP are at high risk of cardiovascular events, but we
demonstrate that a simple therapy can reduce their risk of heart attack,
stroke or cardiovascular death," Ridker said.

JUPITER included nearly 6,801 women and 5,119 members of minority
groups in the randomized cohort.

"For the first time in a major statin prevention trial, we have clear
evidence of benefits in women as well as men, in blacks and Hispanics as
well as Caucasians, and perhaps most importantly, a substantial reduction
in all-cause mortality," he said. "It appears hsCRP predicts high risk even
when cholesterol is low."

However, that issue was not specifically tested in this study.

The benefits of rosuvastatin in people with elevated hsCRP extended
across all subgroups evaluated, including those with low Framingham scores
and those with LDL levels of less than 100mg/dL, Ridker said.

This is consistent with the earlier Heart Protection Study, a largely
secondary prevention study where the benefit of a statin was similar at
high and low levels of LDL cholesterol.

Diet, exercise and smoking cessation are all known to lower hsCRP
levels and are first-line interventions recommended for the general
population to reduce the risk of heart attack and stroke. However, until
now, no large, prospective data study has shown that any pharmacologic
therapy given to those without elevated cholesterol levels but with
elevated hsCRP could prevent cardiovascular events.

Since statins lower both LDL cholesterol and hsCRP (used as a marker of
inflammation), the findings presented at the meeting cannot determine
whether cholesterol lowering, a reduction in inflammation, or a combination
of both are responsible for the reductions seen.

Statements and conclusions of study authors that are presented at
American Heart Association scientific meetings are solely those of the
study authors and do not necessarily reflect association policy or
position. The association makes no representation or warranty as to their
accuracy or reliability. The association receives funding primarily from
individuals; foundations and corporations (including pharmaceutical, device
manufacturers and other companies) also make donations and fund specific
association programs and events. The association has strict policies to
prevent these relationships from influencing the science content. Revenues
from pharmaceutical and device corporations are available at
http://www.americanheart.org/corporatefunding.

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